The Annals of thoracic surgery · 2020
Transcatheter Aortic Valve Replacement in Aortic Regurgitation.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Liu Lulu, Chen Sai, Shi Jun, Qin Chaoyi, Guo Yingqiang
Аннотация
BACKGROUND: Evidence about safety and efficacy of transcatheter aortic valve replacement remains limited for patients with aortic regurgitation.
METHODS: From the Safety and Efficacy of the J-Valve Ausper System in Patients with Severe Aortic Stenosis and/or Aortic Regurgitation Registry, the clinical outcomes of patients with aortic regurgitation from West China Hospital were analyzed.
RESULTS: A total of 134 patients with The Society of Thoracic Surgeons mean risk score of 9.8% underwent transcatheter aortic valve replacement with the J-Valve. Of those, 5 patients (3.7%) were converted to surgical aortic valve replacement. The cumulative all-cause mortality was 3% at 30 days and 3.7% at 6 months. One major bleeding (0.7%), 1 major vascular complication (0.7%), 8 acute kidney diseases (6%), 12 third-degree atrioventricular block (9%), and 1 paravalvular leakage (0.7%) moderate or greater occurred. The device success rate was 96.3%. Mean ejection fraction improved from 52.1% to 57.1% (P < .001) at 30 days and to 58.7% (P < .001 compared with baseline) at 6 months. Mean estimated pulmonary arterial pressure decreased from 29.3 to 23.1 mm Hg (P < .001) at 30 days and to 21.5 mm Hg (P < .001 compared with the baseline) at 6 months. On multivariable analysis, New York Heart Association functional class at 6 months (odds ratio 8.87; 95% confidence interval, 1.36 to 58.06) was independently associated with all-cause mortality at 6 months.
CONCLUSIONS: Transcatheter aortic valve replacement with the J-Valve proved to have acceptable early and midterm clinical outcomes for patients with aortic regurgitation. This is a large-scale single-center study to evaluate the safety and efficacy of transcatheter aortic valve replacement in treating aortic regurgitation.
METHODS: From the Safety and Efficacy of the J-Valve Ausper System in Patients with Severe Aortic Stenosis and/or Aortic Regurgitation Registry, the clinical outcomes of patients with aortic regurgitation from West China Hospital were analyzed.
RESULTS: A total of 134 patients with The Society of Thoracic Surgeons mean risk score of 9.8% underwent transcatheter aortic valve replacement with the J-Valve. Of those, 5 patients (3.7%) were converted to surgical aortic valve replacement. The cumulative all-cause mortality was 3% at 30 days and 3.7% at 6 months. One major bleeding (0.7%), 1 major vascular complication (0.7%), 8 acute kidney diseases (6%), 12 third-degree atrioventricular block (9%), and 1 paravalvular leakage (0.7%) moderate or greater occurred. The device success rate was 96.3%. Mean ejection fraction improved from 52.1% to 57.1% (P < .001) at 30 days and to 58.7% (P < .001 compared with baseline) at 6 months. Mean estimated pulmonary arterial pressure decreased from 29.3 to 23.1 mm Hg (P < .001) at 30 days and to 21.5 mm Hg (P < .001 compared with the baseline) at 6 months. On multivariable analysis, New York Heart Association functional class at 6 months (odds ratio 8.87; 95% confidence interval, 1.36 to 58.06) was independently associated with all-cause mortality at 6 months.
CONCLUSIONS: Transcatheter aortic valve replacement with the J-Valve proved to have acceptable early and midterm clinical outcomes for patients with aortic regurgitation. This is a large-scale single-center study to evaluate the safety and efficacy of transcatheter aortic valve replacement in treating aortic regurgitation.